Sr Executive / Assistant Manager - QA (IVD)

Promea Therapeutics; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Promea Therapeutics in Hyderabad, India is seeking a QA/Compliance professional to uphold cGMP in the plant, review SOPs, and prepare Quality Documents including SMF and Quality Policy. The role also involves reviewing deviations, incidents, change controls and root cause analyses, implementing CAPA, conducting self-inspection reports, handling market complaints and recalls, and providing trainings.

It also covers approval of QA documents and review of vendor lists and master records to ensure

Responsibilities

• Implementation of cGMP in the plant.
• Review of SOPs.
• Preparation of Quality Documents such as SMF and Quality Policy.
• Review and compilation of Deviations, Incidents, Change Control and Root Cause Analysis.
• Review and proper implementation of CAPA.
• Conducting and preparation of Self-inspection reports.
• Handling of Market Complaints & Product Recall.
• Providing trainings.
• Approval of Certificate of Analysis, Specifications, STPs and SOPs.
• Review of approved vendor list of Raw Material & Packing Material.
• Review of Master Packing Card, Master Formula Card, Batch Manufacturing Records & Batch Packing Records.
• Ensuring the Design and development processes meet regulatory and quality standards.
• Risk management associated with IVD products.

Job description

• Responsible for implementation of cGMP in the plant.
• Responsible for review of SOPs.
• Responsible for preparation of Quality Documents such as SMF, Quality Policy etc.
• Responsible for review and compilation of Deviations, Incidents, Change Control and Root Cause Analysis.
• Responsible for review and proper implementation of CAPA.
• Responsible for conducting and preparation of Self-inspection reports.
• Responsible for handling of Market Complaints & Product Recall.
• Responsible for providing trainings.
• Responsible for approval of Certificate of Analysis, Specifications, STPs and SOPs.
• Responsible for review of approved vendor list of Raw Material & Packing Material.
• Responsible for review of Master Packing Card, Master Formula Card, Batch Manufacturing Records & Batch Packing Records.
• Responsible for ensuring the Design and development processes meet regulatory and quality standards.
• Responsible for risk management associated with IVD products.